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Tipifarnib

Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid Malignancies

Ensayo de Kura Oncology, Inc. en Tumor solido avanzado.

Más ensayos de: Tumor sólido avanzado.

Fase

Fase 1

Estado

Interrumpido

Participantes

6

previstos

Centros

3

Fin del objetivo primario

may 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study terminated due to recruitment challenges».

Qué mide

The change from baseline in time-matched difference in QTc interval to post-baseline time points after a single 900 mg dose and multiple 600 mg BID doses of tipifarnib in subjects with Advanced Solid Malignancies (del registro, en inglés) (7 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA Phase I, open-label clinical pharmacology study designed to evaluate the effect of tipifarnib on cardiac repolarization (corrected QT interval \[QTc\] duration) following a single dose of 900 mg and after repeated twice daily administration of 600 mg in subjects with advanced solid malignancies. Subjects will receive a 900 mg single dose at cycle 1 day 1 follow by 600 mg twice a day orally with a meal (Days 2-7 and 15-21) in 28-day cycles. Beginning on Day 2 of Cycle 1, subjects will self-administer 600 mg tipifarnib, orally with a meal, bid for 7 days in alternating weeks (Days 2-7 and 15-21) in 28-day cycles. The secondary objectives are to evaluate the safety and PK of tipifarnib. Series of PK will be collected on day -1 of Cycle 1, Cycle 1 day 1 and Cycle 1 day 7.

Más ensayos de KURA

Todos los de KURA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04865159), actualizada en sep 2023.